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One step hCG Urine Test (pregnancy test for self-testing)

by Beromed GmbH Hospital Products EUDAMED

Withdrawn No longer placed on the EU market

Ref B500654-1

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-24032731500658 Basic UDI-DIDate13 Oct 2026RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Withdrawn

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Model / Reference
B500654-1
Primary DI / UDI-DI
24032731500658
Basic UDI-DI
B-24032731500658
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class IVD devices for self-testing

Manufacturer details

EUDAMED SRN
DE-MF-000007458

Other devices from Beromed GmbH Hospital Products

See all devices from Beromed GmbH Hospital Products →

Properties

  • Self Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No